More information, please [Study As­sess­ment]

posted by AngusMcLean – USA, 2016-05-13 16:40  – Posting: # 16301
Views: 16,939

Hello: It is a very well known drug and many MR formulations are on the market. (You have experience with this drug). All except one formulation show dose proportionality from lowest to highest strength. The one which does not is almost dose proportional. We used that in our clinical protocol to justify our study design of using just two doses. We do have intermediate doses between the low and the high.


There are only two does levels to plot. The relationship is as follows:

LnPK=B0+B1*Ln(dose) where LnPK pertains to Cmax or AUC.

So we have a regression line going through the points: we evaluate the slope (B1), intercept and the confidence intervals about the slope to evaluate dose proportionality. Brian Smith in Pharm Research year 2000 has extended the approach from the original UK working party. It seems that you can calculate intrasubject and intersubject variance e.g. for AUC and partial AUC from this approach. I do not follow how to do it. I use the usual intrasubject and intersubject values from Phoenix WinNonlin 6.4 and I am happy with that.

Angus

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,567 posts in 4,150 threads, 1,340 registered users;
online 7 (0 registered, 7 guests [including 6 identified bots]).
Forum time (Europe/Vienna): 00:25 CEST

Mediocrity knows nothing higher than itself,
but talent instantly recognizes genius.    Arthur Conan Doyle

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5